Advanced colorectal cancer or stomach cancer
Conditions
Interventions
experimental group:Anlotinib combined with Duvalizumab
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study and sign informed consent, with good compliance and follow-up 2. Only patients aged 18-75 years were enrolled and their life expectancy was at least 6 months; 3. Patients with advanced gastric cancer or advanced colorectal cancer confirmed by pathology and imaging diagnosis. Note: The presence of distant metastases should be confirmed by CT or MR scan. Bone scan should be performed if bone metastases are suspected. Local radiation therapy for pain relief was allowed for bone metastases. 4. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 was applied to measure foci (of which the longest diameter at baseline was >= 10mm (lymph nodes, short diameter was required to be >= 15mm). Local radiotherapy for target lesions is not allowed. 5. Patients with advanced MSS gastric cancer or advanced colorectal cancer who have failed the current standard second-line treatment or are intolerant to third-line treatment. 6. ECOG 1 minute or less. 7. Tumor specimens that can be used to detect THE status of PD-L1, MSI, B-RAF and K-RAS can be provided. This test requires the patient to provide paraffin embedded biopsy specimen or white sheet. 8. White blood cells >= 4 x 10^9/L, platelets without blood transfusion >= 100 x 10^9/L, absolute value of neutrophils (ANC) without granulocyte stimulation factor >= 1.5 x 10^9/L, hemoglobin >= 90 g/L. 9. Bilirubin 45 ml/min. 11. Serum albumin >= 25 g/L (2.5 g/dL); 12. INR or APTT <= 1.5 times ULN; 13. Hepatitis B/C surface antigen positive patients need to be tested for HEPATITIS B/C DNA virus quantitative test, only < the upper limit of the normal test value patients can be enrolled, and long-term use of anti-hepatitis B/C virus drugs; 14. Drug elution time: 28 days or 5 drug half-lives away from the last medication.
Exclusion criteria
Exclusion criteria: 1. Allergic to any test drug and its excipients, or has a history of severe allergy, or is contraindicated to the test drug; 2. Have a history of autoimmune disease or are in the active stage; 3. Have received allogeneic bone marrow transplant or organ transplant before; 4. Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ACTIVE pneumonia confirmed by CT; 5. HIV positive; 6. Active hepatitis B or C (hepatitis B and C virus quantification higher than normal); 7. Active tuberculosis; 8. Uncontrolled cancer pain; 9. Administered live attenuated vaccine within 4 weeks before the start of the study, or expected to be administered during the trial or within 5 months after the end of the trial; 10. Previous use of immunotherapy, including CTLA4, anti-PD-1, or anti-PD-L1 monoclonal antibody; 11. CT indicated active pulmonary inflammation; 12. Glucocorticoids or immunosuppressants were administered throughout the body for 2 weeks prior to the start of the trial. Inhaled glucocorticoids and halocorticoids were allowed; 13. Steroid use contraindications; 14. Severe cardiovascular disease, myocardial infection, ARTERiovenous thrombosis or previous ARTERiovenous thrombosis events within 6 months prior to the start of the trial, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis and pulmonary embolism, arrhythmias, unstable angina; 15. Patients with any or current brain metastases; 16. A history of other malignancies prior to 5 years, except carcinoma in situ of the cervix, non-melanoma skin cancer or stage I uterine cancer; 17. >= NCI CTCAE level 2 peripheral neuropathy; 18. Uncontrolled or symptomatic hypercalcemia; 19. Infections requiring antibiotics within 14 days of the start of the trial; 20. Persons with a history of abuse of psychotropic substances and who cannot be cured or have mental disorders; 21. Patients with any physical signs or history of bleeding, regardless of severity; 22. Non-diagnostic surgery within 4 weeks prior to the start of the trial; 23. Any other disease for which there is evidence of a need to restrict the use of experimental drugs; 24. Participate in, or plan to participate in, other tests within 30 days of the start of the test; 25. Receive other experimental drugs within 28 days before the start of the trial 26. Women who are pregnant or breastfeeding, or who plan to become pregnant within five months of the end of treatment; Women of childbearing age are required to receive blood pregnancy tests within 7 days before the start of the trial; 27. Contraindications for the use of antinib or PD-L1 monoclonal antibody; 28. Msi-h /dMMR patients with advanced gastric cancer or colorectal cancer. 29. Patients with any severe and/or uncontrolled disease include: A) patients with hypertension whose systolic blood pressure >= 150 mmHg and diastolic blood pressure >= 100mmHg cannot be well controlled by single antihypertensive drug therapy; Or use two or more antihypertensive drugs to control blood pressure; B) Having grade II or above myocardial ischemia or infarction, arrhythmia (including QTc >= 480ms), and grade 2 or above congestive heart failure (New York Heart Association (NYHA) classification); C) Active or uncontrolled severe infection (NCI-CTC AE V4.03 grade >= 2); D) urine routine indicated urinary protein >= ++, and confirmed 24-hour quantitative urinary protein > 1.0g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT; | — |
Countries
China
Contacts
Public ContactWensheng Qiu
The Affiliated Hospital of Qingdao University
Outcome results
None listed